{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-07-18", "results": { "skip": 0, "limit": 1, "total": 62 } }, "results": [ { "spl_product_data_elements": [ "12 hr relief cough dm dextromethorphan polistirex DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN D&C RED NO. 30 ALUMINUM LAKE FD&C BLUE NO. 1 ALUMINUM LAKE GLYCERIN HIGH FRUCTOSE CORN SYRUP METHYLPARABEN POLYSORBATE 80 POLYVINYL ACETATE POVIDONE, UNSPECIFIED PROPYLPARABEN WATER SODIUM METABISULFITE SODIUM POLYSTYRENE SULFONATE SUCROSE TARTARIC ACID TRAGACANTH TRIACETIN XANTHAN GUM" ], "active_ingredient": [ "Active ingredient (in each 5 mL) Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide" ], "purpose": [ "Purpose Cough suppressant" ], "indications_and_usage": [ "Uses temporarily relieves • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants • the impulse to cough to help you get to sleep" ], "warnings": [ "Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Allergy Alert: Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions. Ask a doctor before use if you have • chronic cough that lasts as occurs with smoking, asthma or emphysema • cough that occurs with too much phlegm (mucus) Stop use and ask a doctor if • side effects occur. You may report side effects to FDA at 1-800-FDA-1088. • cough lasts more than 7 days, cough comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "do_not_use": [ "Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Allergy Alert: Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions." ], "ask_doctor": [ "Ask a doctor before use if you have • chronic cough that lasts as occurs with smoking, asthma or emphysema • cough that occurs with too much phlegm (mucus)" ], "stop_use": [ "Stop use and ask a doctor if • side effects occur. You may report side effects to FDA at 1-800-FDA-1088. • cough lasts more than 7 days, cough comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "dosage_and_administration": [ "Directions • shake bottle well before use • measure only with dosing cup provided • do not use dosing cup with other products • dose as follows or as directed by a doctor • mL = milliliter adults and children 12 years of age and over 10 mL every 12 hours, not to exceed 20 mL in 24 hours children 6 to under 12 years of age 5 mL every 12 hours, not to exceed 10 mL in 24 hours children 4 to under 6 years of age 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours children under 4 years of age do not use" ], "dosage_and_administration_table": [ "
adults and children 12 years of ageand over10 mL every 12 hours, not to exceed 20 mL in 24 hours
children 6 to under 12 years of age5 mL every 12 hours, not to exceed 10 mL in 24 hours
children 4 to under 6 years of age2.5 mL every 12 hours, not to exceed 5 mL in 24 hours
children under 4 years of agedo not use
" ], "storage_and_handling": [ "Other information • each 5 mL contains: sodium 5 mg • store at 20° to 25°C (68° to 77°F) • dosing cup provided" ], "inactive_ingredient": [ "Inactive ingredients artificial grape flavor, D&C Red #30 aluminum lake, FD&C Blue #1 aluminum lake, glycerin, high fructose corn syrup, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum" ], "questions": [ "Questions or comments? 1-800-719-9260" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel CVS TM Grape-Flavored Liquid 12 HR RELIEF COUGH DM Dextromethorphan Polistirex Extended-Release Oral Suspension Cough Suppressant Compare to Delsym® active ingredient No Added Alcohol | DAY OR NIGHT 3 FL OZ (89 mL) Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions. 12-hr-relief-cough-dm" ], "set_id": "03c44e2f-d6e3-4c78-9c9a-92d1708a62fe", "id": "2e3f0d92-63a5-4b45-8666-14009abb4080", "effective_time": "20260708", "version": "2", "openfda": { "application_number": [ "ANDA091135" ], "brand_name": [ "12 hr relief cough dm" ], "generic_name": [ "DEXTROMETHORPHAN POLISTIREX" ], "manufacturer_name": [ "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED" ], "product_ndc": [ "51316-943" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DEXTROMETHORPHAN HYDROBROMIDE" ], "spl_id": [ "2e3f0d92-63a5-4b45-8666-14009abb4080" ], "spl_set_id": [ "03c44e2f-d6e3-4c78-9c9a-92d1708a62fe" ], "package_ndc": [ "51316-943-21" ], "is_original_packager": [ true ], "unii": [ "9D2RTI9KYH" ] } } ] }